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An Acceptance-Based Behavioral Intervention vs. Nutritional Counselling for Weight Loss in Psychotic Illness

C

Center for Addiction and Mental Health (CAMH)

Status

Completed

Conditions

Psychotic Illnesses

Treatments

Other: Nutritional Counselling
Behavioral: Acceptance-Based Behavioral Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02130596
132/2013

Details and patient eligibility

About

Obesity occurs at 2-3 times the general population rate in persons living with a psychotic illness. The risk of obesity-related serious medical conditions like diabetes and heart disease are also two to three times higher in this population. Traditional behavioral weight management approaches help more than half of these individuals to lose weight, but a significant proportion are not helped. This pilot study is intended to determine the feasibility, efficacy, acceptability, and potential clinical utility of an intervention that integrates mindfulness, acceptance, distress tolerance, and motivation and commitment combined with traditional behavioral strategies for weight loss. This is the first study to investigate such an acceptance-based behavioral intervention for weight loss in psychotic illness. The results from this study will help to determine whether future research in this area is warranted with a larger sample, over a longer period of time.

Primary hypothesis: Weight loss will be greater in individuals who receive the acceptance based behavioral intervention, relative to those who receive nutritional counseling.

Enrollment

16 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • BMI > 25.0
  • Diagnosed psychotic illness (i.e., schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, major depressive disorder with psychotic features, substance-induced psychotic disorder, and psychotic disorder not otherwise specified).

Exclusion criteria

  • Inability to provide informed consent
  • Prediabetes or type 2 diabetes mellitus
  • Current enrollment in another formal weight management program
  • Brief Psychiatric Rating Scale (BPRS) ratings of 4 or more on any one of Grandiosity (Item #6), Suspiciousness (Item #7), Hallucinations (Item #8), Unusual Thought Content (Item #9), or Conceptual Disorganization (Item #10), or a BPRS total score of 80 or more.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

16 participants in 2 patient groups

Acceptance-Based Behavioral Intervention
Experimental group
Treatment:
Behavioral: Acceptance-Based Behavioral Intervention
Nutritional Counselling
Active Comparator group
Treatment:
Other: Nutritional Counselling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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